Mucus testing processes and devices

ABSTRACT

A mucus sample from a bodily cavity is introduced between inner and outer bearing members, one of which is fixed, one of which is biased, and both of which have bearing surfaces of predetermined surface finish. Relative mechanical movement of the members indicates menstrual cycle phase.

RELATED APPLICATION

.[.The present application.]. .Iadd.Patent No. 3,982,423, issued Sept.28, 1976.Iaddend., is a continuation-in-part of .[.my earlier.].application Ser. No. 462,298, filed Apr. 19, 1974, now abandoned, which.[.in turn.]. is a continuation-in-part of .[.my earlier.]. applicationSer. No. 433,767, filed Jan. 16, 1974, now abandoned which .[.in turn.].is a continuation-in-part of .[.my earlier.]. application Ser. No.300,187, filed Oct. 24, 1972.[.. The present application also is.]. ,.Iadd.now abandoned and .Iaddend.a continuation-in-part of .[.myearlier.]. application Ser. No. 472,611, filed May 23, 1974, .Iadd.nowabandoned .Iaddend. which .[.in turn.]. is a continuation-in-part of.[.aforesaid.]. .Iadd.said .Iaddend.application Ser. No. 300,187, filedOct. 24, 1972, .Iadd.now abandoned. .Iaddend.The present invention alsois related to application Ser. No. 629,700, filed Nov. 7, 1975, which isa continuation of aforesaid application Ser. No. 472,611, filed May 23,1974.

BACKGROUND OF THE INVENTION

The present invention relates to processes and devices for determiningthe phase of the menstrual cycle and, particularly, to indicating therheological properties of bodily mucus, particularly cervical mucusand/or oral mucus, in order to predict the inception and to indicate thepresence of ovulation. The present invention thus is concerned withconception control. It has been found that mucus samples from thevaginal and oral cavities undergo distinct in-phase rheological changesduring the menstrual cycle. Although the changes in the cervical mucusare much more noticeable than the changes in the oral mucus, bothchanges are readily determinable. During the immediate preovulatoryphase, for a period of one to three days under estrogen domination, themucus is profuse and watery. During the postovulatory phase, underprogestation, the mucus becomes less abundant and more viscous. Inhealthy women with normal menstrual cycles, as is well documented in themedical literature, ovulation usually occurs between the 12th and 14thday prior to the next menstrual period (and not after the precedingperiod). Specifically, cervical mucus is most hydrated at the time ofovulation, containing 97 to 98% water, and is relatively dehydrated atother times, containing only 80 to 90% water. The solid residue afterdesiccation may range from 2% during ovulation to 20% at other times, aten fold increase. Predicting ovulation on the basis of the precedingmenstrual period by counting the number of days elapsed between the endof the preceding period and the presumed mid-cycle ovulatory phase (therhythm method) is prone to errors because it is impossible to predictthe onset of the next menstrual period. It is possible to predictovulation on the basis of hormonal changes in the blood or chemicalchanges in the mucus but present procedures for such analyses are usefulonly in special cases because the procedures for such analyses areuseful only in special cases because the procedures involved are lengthyand costly. At present, there are no known reliable on-the-spottechniques capable of providing the information necessary for predictionor confirmation of ovulation during or immediately following examinationof a patient.

SUMMARY OF THE INVENTION

The primary object of the present invention is to provide processes anddevices, for testing bodily mucus, by introducing the mucus betweeninner and outer bearing members, one of which is fixed, one of which isbiased, and both of which have bearing surfaces of predetermined surfacefinish, the resulting presence or absence of mechanical movementconstituting an indicium of ovulation. The inner and outer bearingmembers are individually separable from each other and from a support sothat they can be sterilized or replaced. The motions between the bearingmembers are either rotational or reciprocal. Ordinarily, the mucus issupplied to one of the bearing surfaces while the bearing members aredissembled from each other and the mucus is extruded between the bearingsurfaces when they are assembled with each other. In one form, one ofthe bearing members is fixed on a suitable support and the other isprovided with a biasing member, e.g. a weight or a spring, which exertssufficient force to cause relative movement when the highly fluid mucushas been sampled during the ovulatory phase but insufficient force tocause relative movement when the viscous mucus has been sampled at othertimes during the menstrual period. In another form, one of the bearingmembers is an extension of an elongated probe for insertion into thevaginal cavity and retrieval on the extension of a cervical mucusspecimen. In accordance with the present invention, it has beendiscovered that the foregoing operation requires that the bearingmembers have inner and outer bearing surfaces, each characterized by asurface finish having valleys and peaks of from 8 to 125 microinches inaverage valley to peak height, such a surface finish, in variousembodiment, is provided by machining or etching random valleys and peaksor machining or etching regularly spaced prismatic facets or the like.It is believed that this specific surface roughness controls slippage ofthe mucus with respect to the bearing surfaces and ensures theoccurrence of predetermined shear within the mucus interior.

Other objects of the present invention will in part be obvious and willin part appear hereinafter.

The invention accordingly comprises the processes and devices, togetherwith their steps, parts and interrelationships, which are exemplified inthe present disclosure, the scope of which will be indicated in theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and objects of the presentinvention, reference is made to the following detailed description,which is to be taken in connection with the accompanying drawings,wherein:

FIG. 1 is a perspective view of a device embodying the presentinvention, with parts assembled for the performance of certain steps ofa process of the present invention;

FIG. 2 illustrates the device of FIG. 1, with its parts dissembled forthe performance of certain steps of a process of the present invention;

FIG. 3 illustrates an auxiliary instrument useful in the performance ofcertain steps of the present invention;

FIG. 4 illustrates another auxiliary instrument useful in accordancewith the present invention;

FIG. 5 is a front elevation of another device embodying the presentinvention;

FIG. 6 is a side elevation of the device of FIG. 5;

FIG. 7 is a cross-sectional view, along the axis, of a component usefulin connection with the operation of the device of FIG. 6;

FIG. 8 is a front elevation of a further device embodying the presentinvention;

FIG. 9 is a perspective view of another device embodying the presentinvention with parts dissembled for the performance of certain steps ofthe process of the present invention; and

FIG. 10 is a perspective view of the device of FIG. 9, with partsassembled for the performance of other steps of the present invention.

DETAILED DESCRIPTION

Generally, the device of FIG. 1 comprises an inner bearing member 20, anouter bearing member 22, a biasing member 46, a support 24, an indicia26. Support 24, which includes a horizontal base 28 and an upright plate30, is composed of a suitable plastic such as methyl methacrylate orpolycarbonate. Plate 30 is provided centrally with a horizontallyextending notch 32 having an axis that is perpendicular to the faces ofplate 30 and a rectangular cross section.

Inner bearing member 20 is in the form of a short cylindrical rod havingalong its axis, a rearward extension or key 34 and a forward cylindricalbearing surface 36. Key 34, which snugly and removably fits into slot32, maintains a horizontal orientation of the axis of bearing member 20when bearing member 20 and support 24 are assembled. Outer bearingmember 22 is in the form of a disc having an axis, along which aredisposed forward and rearward parallel flat faces 38,40, an outercylindrical periphery 42 and an inner cylindrical bearing surface 44.Outer bearing surface 36 and inner bearing surface 44 snugly androtatably fit each other when bearing elements 20 and 22 are assembled.

In accordance with the present invention, each of bearing surfaces 36,44requires a surface finish ranging from 8 to 125 microinches(approximately 0.2 to 3.2 microns) in average valley to peak height.Also, the spacing of tolerance between the bearing surfaces ranges from0.01 to 10.0 mils (approximately 0.254 to 254.0 microns) and preferablyfrom 1 to 5 mils (approximately 25.4 to 127.0 microns). Preferably theaxial thickness of outer bearing member 22 ranges from 1/4 to 2 inches(approximately 6.35 to 50.8 mm). Preferably each of the bearing membersis composed of a dimensionally stable, sterilizable material, forexample, a vitreous material such as glass, a metallic material such asstainless steel, or a plastic material such as methyl methacrylate.

Extending through periphery 42 into the bore of outer bearing member 22is a bore 45. Frictionally secured within bore 45 is an internallythreaded sleeve 47 composed, for example, of plastic or metal. Turnedinto sleeve 47 is weighted plug 46, which is externally threaded andwhich is composed, for example, of metal or the like. Plug 46 has anexternal screwdriver slot by which the position of the plug with respectto the axis of the outer bearing member can be adjusted precisely.

Indicia 26 include an outwardly directed arrow 50 on outer bearingmember 22 and an inwardly directed arrow 52 on plate 30. When the innerand outer bearing members are assembled with mucus between their bearingsurfaces, weighted plug 46 is in a position to cause rotary motion ofthe outer bearing member with respect to the inner bearing member.Adjacent to arrow 52 on plate 30 is a green spot 54 and adjacent toexternal bearing member 22 at 90° from green spot 54 is a red spot 56.The arrangement is such that when the mucus between the bearing surfacesis relatively watery, weighted plug 46 rotates outer bearing member 22in a clockwise direction so that arrow 50 points toward red spot 56. Onthe other hand, when the mucus is relatively viscous, weighted plug 46is incapable of rotating outer bearing member 22 so that arrow 50remains pointed toward green spot 54.

One process of the present invention involves the use of sterile innerand outer bearing members 20,22 as follows. First, inner bearing member20 is assembled with plate 30 by inserting key 34 into slot 32. Next, asample of cervical mucus is obtained by inserting a disposable probe 60,having an elastomeric scoop 62 at its extremity, through the vaginalcavity into contact with the cervix in order to retain a sample ofcervical mucus 63. Next, this cervical mucus is transferred to one ofbearing surfaces 36,44 and the inner and outer bearing members areassembled by fitting outer bearing member 22 onto inner bearing member20, the arrangement being such that the cervical mucus is extrudedbetween the bearing surfaces. Next outer bearing member 22 is rotatedmanually a predetermined number of times, usually from one to threetimes, until arrows 50,52 are aligned. Then outer bearing member 22 isreleased. Finally, the rest position of arrow 50 relative to green spot54 and red spot 56 is indicative of the presence or absence ofovulation.

In an alternative process, oral mucus, i.e. saliva is removed from themouth by an eye dropper 64 having a tube 66 with a restricted end 68 andan elastomeric bulb 70. Here, saliva is applied to one of bearingsurfaces 36,44 simply by manually squeezing bulb 70 and extruding salivathrough opening 68. This process otherwise is identical to thatdescribed above in connection with cervical mucus.

The device of FIGS. 5, 6, and 7 includes a base 71 having a bearing bed72. Resting on bearing bed 72 is a rod 74, which extends forwardly toreceive a ring 76. The forward extremity of rod 74 and the internalperiphery of ring 76 provide bearing surfaces of the type describedabove for the receipt of mucus. Depending from ring 76 is a trippingelement 78. Extending forwardly from the base 71 is a cantilever shaft80 on which is journaled a finger 82 that is biased into contact withtripping element 78. The bias is effected by a weight 84, which iscarried by a threaded screw 86 and which is adjustable by rotation ofthe threaded screw. Associated with rod 74 is a bow 87, in the form of arod having a rubber outer surface 88. Bow 87, when manually advancedfrom one end to the other in contact with a surface or rod 74, rotatesrod 74 a predetermined number of rotational cycles.

In operation, with ring 76 removed, mucus is supplied to the forwardextremity of rod 74 by a scoop or an eyedropper of the types describedin connection with the device of FIG. 1. Thereafter ring 76 is fittedonto the end of rod 74 and bow 87 manually is stroked from one end tothe other along the periphery of rod 74 in order to cause its rotation.In the event that the mucus is relatively watery, rotation or ring 76will not occur and tripping element 78 will not be actuated. However, ifthe mucus is relatively viscous, rotation of rod 74 will cause trippingmechanism 78 to be actuated.

The embodiment of FIG. 8 is analogous to the embodiment of FIGS. 5, 6,and 7 in all respects except that ripping arrangement 82, 84, 86 isreplaced by a calibrated tension gage 90, which includes a trippingfinger 92 that is biased by a weight or spring or the like, a memorypointer 96, and an indicator light 98.

The embodiment of FIGS. 9 and 10 includes an elongated cylindrical probe100, at the forward extremity of which is a cylindrical extension 102 ofreduced diameter that is isolated from the remainder of the probe by ashoulder 104. The forward extremity of extension 102 is rounded as at106. Associated with probe 100 is an annulus 108 having an inner bore110 and forward and rearward flat parallel faces 112, 114. The outerbearing surface of extension 102 and the inner bearing surface of bore110 snugly fit each other when ring 108 and probe 100 are assembled.Extending from the periphery of ring 108 is a threaded shaft 116 havingturned thereon an adjustable nut 118, the shaft and the nut serving asan adjustable torque weight. Probe 100 and ring 108 are composed of thesame materials as are their counterparts in FIGS. 1 and 2. Also thedimensions and grit characteristics of extension bearing surface 102 andof bore bearing surface 110 are the same as are their counterparts inFIGS. 1 and 2.

In operation of the device of FIGS. 9 and 10, first probe 100 isinserted into the vaginal cavity so that extension 102 contacts thecervix, by which a quantity of cervical mucus is retained on the bearingsurface of extension 102. Next probe 100 is withdrawn from the vaginalcavity and is assembled with ring 108 so that extension 102 is insertedinto bore 110 and rearward movement of ring 108 is limited by shoulder104. At this point cervical mucus is extruded between the bearingsurfaces of bore 110 and extension 102. Then a user, while holding probe100 horizontally in one hand, moves shaft 116 into horizontalorientation with the other hand. Finally when shaft 116 is released,rotation of ring 108 relative to probe 100, under the torque of weight116, 118 will or will not occur. Menstrual cycle phase thereby will beindicated in accordance with the present invention.

It will be appreciated that the motion of devices herein have been shownas being rotational as opposed to reciprocable. However, the principlesof the present invention apply as well to the reciprocating internal andexternal bearing members although such devices are less preferred. Sincecertain changes may be made in the present disclosure without departingfrom the scope of the present invention, it is intended that all mattershown in the accompanying drawings or described in the foregoingspecification be interpreted in an illustrative and not in a limitingsense.

What is claimed is:
 1. A device for testing mucus from a bodily cavity,said device comprising a base, inner bearing means and outer bearingmeans composed of glass, said inner bearing means and said outer bearingmeans being arranged for motion with respect to each other on said base,means for biasing said inner bearing means and said outer bearing meansfor said motion, and means for indicating the occurrence of said motion,said inner bearing means and said outer bearing means have inner andouter cylindrical bearing surfaces, each of said bearing surfaces havinga surface finish ranging from approximately 0.2 microns to 3.2 micronsin valley to peak height, the clearance between said bearing surfacesranging from approximately 0.25 microns to 254.0 microns, said means forindicating including indicia movable with at least one of said bearingelements and indicia fixed in operation with respect to said base, saidbase including an upright plate having a slot, said inner bearing memberhaving a key, said key being removably retained by said slot, one ofsaid indicia being located on said plate and the other of said indiciabeing located on said outer bearing member.
 2. A device for testingmucus from a bodily cavity, said device comprising a base, inner bearingmeans and outer bearing means composed of glass, said inner bearingmeans and said outer bearing means being arranged for motion withrespect to each other on said base, means for biasing said inner bearingmeans and said outer bearing means for said motion, and means forindicating the occurrence of said motion, said inner bearing means andsaid outer bearing means have inner and outer cylindrical bearingsurfaces, each of said bearing surfaces having a surface finish rangingfrom approximately 0.2 micron to 3.2 microns in valley to peak height,the clearance between said bearing surfaces ranging from approximately0.25 microns to 254.0 microns, said means for indicating includingindicia movable with at least one of said bearing elements and indiciafixed in operation with respect to said base, said means for indicatingincluding a calibrated tension gauge, said calibrated tension gaugebeing mounted on said base.
 3. A device for testing mucus from a bodilycavity, said device comprising a base, inner bearing means and outerbearing means composed of glass, said inner bearing means and said outerbearing means being arranged for motion with respect to each other onsaid base, means for biasing said inner bearing means and said outerbearing means for said motion, and means for indicating the occurrenceof said motion, said inner bearing means and said outer bearing meanshave inner and outer cylindrical bearing surfaces, each of said bearingsurfaces having a surface finish ranging from approximately 0.2 micronsto 3.2 microns in valley to peak height, the clearance between saidbearing surfaces ranging from approximately 0.25 microns to 254.0microns, said means for indicating including indicia movable with atleast one of said bearing elements and indicia fixed in operation withrespect to said base, said base including an elongated rod, said innerbearing member projecting from said rod and being substantially coaxialtherewith, said rod providing a shoulder for limiting axial movement ofsaid outer bearing member with respect thereto.
 4. A device for testingmucus from a bodily cavity, said device comprising a base, inner bearingmeans and outer bearing means, said inner bearing means and said outerbearing means being arranged for motion with respect to each other onsaid base, means for biasing said inner bearing means and said outerbearing means for said motion, and means for indicating the occurrenceof said motion, said inner bearing means and said outer bearing meanshave inner and outer cylindrical bearing surfaces, each of said bearingsurfaces having a surface finish ranging from approximately 0.2 micronsto 3.2 microns in valley to peak heights, the clearance between saidbearing surfaces ranging from approximately 0.25 microns to 254.0microns, said means for indicating including indicia movable with atleast one of said bearing elements and indicia fixed in operation withrespect to said base, said base including an upright plate having aslot, said inner bearing member having a key, said key being removablyretained by said slot, one of said indicia being located on said plateand the other of said indicia being located on said outer bearingmember.
 5. A device for testing mucus from a bodily cavity, said devicecomprising a base, inner bearing means and outer bearing means, saidinner bearing means and said outer bearing means being arranged formotion with respect to each other on said base, means for biasing saidinner bearing means and said outer bearing means for said motion, andmeans for indicating the occurrence of said motion, said inner bearingmeans and said outer bearing means have inner and outer cylindricalbearing surfaces, each of said bearing surfaces having a surface finishranging from approximately 0.2 microns to 3.2 microns in valley to peakheight, the clearance between said bearing surfaces ranging fromapproximately 0.25 microns to 254.0 microns, said means for indicatingincluding indicia movable with at least one of said bearing elements andindicia fixed in operation with respect to said base, said means forindicating including a calibrated tension gauge, said calibrated tensiongauge being mounted on said base.
 6. A device for testing mucus from abodily cavity, said device comprising a base, inner bearing means andouter bearing means, said inner bearing means and said outer bearingmeans being arranged for motion with respect to each other on said base,means for biasing said inner bearing means and said outer bearing meansfor said motion, and means for indicating the occurrence of said motion,said inner bearing means and said outer bearing means have inner andouter cylindrical bearing surfaces, each of said bearing surfaces havinga surface finish ranging from approximately 0.2 microns to 3.2 micronsin valley to peak height, the clearance between said bearing surfacesranging from approximately 0.25 microns to 254.0 microns, said means forindicating including indicia movable with at least one of said bearingelements and indicia fixed in operation with respect to said base, saidbase including an elongated rod and stop means, said inner bearingmember projecting from said rod and being substantially coaxialtherewith, said stop means limiting axial movement of said outer bearingmember with respect to said rod.
 7. A device for testing mucus from abodily cavity, said device comprising a base, inner bearing means andouter bearing means, said inner bearing means and said outer bearingmeans being arranged for motion with respect to each other on said base,means for biasing said inner bearing means and said outer bearing meansfor said motion, and means for indicating the occurrence of said motion,said inner bearing means and said outer bearing means have inner andouter cylindrical bearing surfaces, each of said bearing surfaces havinga surface finish ranging from approximately 0.2 microns to 3.2 micronsin valley to peak height, the clearance between said bearing surfacesranging from approximately 0.25 microns to 254.0 microns, said means forindicating including indicia movable with at least one of said bearingelements and indicia fixed tin operation with respect to said base, saidbase including an elongated rod, said inner bearing member projectingfrom said rod and being substantially coaxial therewith, said rodincluding means for limiting axial movement of said outer bearing memberwith respect to said rod.